The following data is part of a premarket notification filed by Ray Co., Ltd. with the FDA for Rct800.
| Device ID | K181452 |
| 510k Number | K181452 |
| Device Name: | RCT800 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Ray Co., Ltd. 332-7, Samsung 1-ro Hwaseong-si, KR 18380 |
| Contact | Changhwan Lee |
| Correspondent | Changhwan Lee Ray Co., Ltd. 332-7, Samsung 1-ro Hwaseong-si, KR 18380 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800003004089 | K181452 | 000 |
| 08800003004072 | K181452 | 000 |
| 08800003004065 | K181452 | 000 |
| 08800003004058 | K181452 | 000 |
| 08800003004041 | K181452 | 000 |
| 08800003004034 | K181452 | 000 |
| 08800003004027 | K181452 | 000 |
| 08800003004010 | K181452 | 000 |